Notice2023-22976
Guidance Documents Referencing Pre-Existing Tobacco Products; Guidance for Industry; Availability; Withdrawal
Primary source
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Published
October 18, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is announcing the availability of revised final guidances for industry entitled "Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions," and "Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007." Following the issuance of the final rules entitled "Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports" (SE) and "Premarket Tobacco Product Applications and Recordkeeping Requirements" (PMTA), FDA has made minor updates to these guidances for consistency with the terminology used in those rules. FDA is also announcing the withdrawal of the final guidances entitled "Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products," and "Investigational Use of Deemed, Finished Tobacco Products That Were on the U.S. Market on August 8, 2016, During the Deeming Compliance Periods," and a draft guidance entitled "Substantial Equivalence Reports: Manufacturer Requests for Extensions or to Change the Predicate Tobacco Product," which are obsolete due to the issuance of the SE final rule or the end of the compliance period for deemed, finished tobacco products that were on the U.S. market on August 8, 2016.
Full Text
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<title>Federal Register, Volume 88 Issue 200 (Wednesday, October 18, 2023)</title>
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[Federal Register Volume 88, Number 200 (Wednesday, October 18, 2023)]
[Notices]
[Pages 71873-71875]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-22976]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-D-4128]
Guidance Documents Referencing Pre-Existing Tobacco Products;
Guidance for Industry; Availability; Withdrawal
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of revised final guidances for industry entitled
``Demonstrating the Substantial Equivalence of a New Tobacco Product:
Responses to Frequently Asked Questions,'' and ``Establishing That a
Tobacco Product Was Commercially Marketed in the United States as of
February 15, 2007.'' Following the issuance of the final rules entitled
``Content and Format of Substantial Equivalence Reports; Food and Drug
Administration Actions on Substantial Equivalence Reports'' (SE) and
``Premarket Tobacco Product Applications and Recordkeeping
Requirements'' (PMTA), FDA has made minor updates to these guidances
for consistency with the terminology used in those rules. FDA is also
announcing the withdrawal of the final guidances entitled ``Section
905(j) Reports: Demonstrating Substantial Equivalence for Tobacco
Products,'' and ``Investigational Use of Deemed, Finished Tobacco
Products That Were on the U.S. Market on August 8, 2016, During the
Deeming Compliance Periods,'' and a draft guidance entitled
``Substantial Equivalence Reports: Manufacturer Requests for Extensions
or to Change the Predicate Tobacco Product,'' which are obsolete due to
the issuance of the SE final rule or the end of the compliance period
for deemed, finished tobacco products that were on the U.S. market on
August 8, 2016.
DATES: The announcement of the guidance is published in the Federal
Register on October 18, 2023.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked, and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2023-D-4128 for ``Guidance Documents Referencing Pre-Existing
Tobacco Products.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential
[[Page 71874]]
Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of these guidances to the
Center for Tobacco Products, Food and Drug Administration, Document
Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request or include a Fax number to which
the guidances may be sent. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance documents.
FOR FURTHER INFORMATION CONTACT: Natalie Gibson, Center for Tobacco
Products, Food and Drug Administration, Document Control Center, 10903
New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993-0002,
877-287-1373, email: <a href="/cdn-cgi/l/email-protection#1e5d4a4e4c7b796b727f6a7771706d5e787a7f3076766d30797168"><span class="__cf_email__" data-cfemail="72312622201715071e13061b1d1c01321416135c1a1a015c151d04">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
On June 22, 2009, the Family Smoking Prevention and Tobacco Control
Act (Pub. L. 111-31) (Tobacco Control Act) was signed into law. The
Tobacco Control Act grants FDA authority to regulate the manufacture,
marketing, and distribution of tobacco products to protect public
health generally and to reduce tobacco use by youth. FDA is announcing
the availability of revised final guidances for industry, collectively
entitled ``Guidance Documents Referencing Pre-Existing Tobacco
Products.''
In the PMTA final rule (86 FR 55300, October 5, 2021) and the SE
final rule (86 FR 55224, October 5, 2021), FDA has changed the term
``grandfathered tobacco product'' to ``pre-existing tobacco product''
because it more appropriately describes these products. Specifically,
FDA considers a ``pre-existing tobacco product'' to mean a tobacco
product that was commercially marketed in the United States as of
February 15, 2007. FDA also made other minor changes to the revised
guidances to reflect updated terminology used in the SE final rule,
when appropriate. Details of the changes are described in the revision
history page included with each guidance.
FDA is also withdrawing three guidances that are obsolete due to
the issuance of the SE final rule or due to the end of the compliance
period for deemed, finished tobacco products that were on the U.S.
market on August 8, 2016. The guidances along with their docket numbers
and status are listed in table 1.
Table 1--Revised and Withdrawn Guidances
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Title Docket No. Status
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Demonstrating the Substantial FDA-2011-D-0147... Revised.
Equivalence of a New Tobacco
Product: Responses to
Frequently Asked Questions.
Establishing That a Tobacco FDA-2011-D-0125... Revised.
Product Was Commercially
Marketed in the United States
as of February 15, 2007.
Investigational Use of Deemed, FDA-2016-D-3276... Withdrawn.
Finished Tobacco Products That
Were on the U.S. Market on
August 8, 2016, During the
Deeming Compliance Periods.
Section 905(j) Reports: FDA-2010-D-0635... Withdrawn.
Demonstrating Substantial
Equivalence for Tobacco
Products.
Substantial Equivalence Reports: FDA-2014-D-0800... Withdrawn.
Manufacturer Requests for
Extensions or to Change the
Predicate Tobacco Product,
Draft Guidance.
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The revised final guidances are being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115) and represent the
current thinking of FDA on, among other things, the incorporation of
the term ``pre-existing tobacco product.'' They do not establish any
rights for any person and are not binding on FDA or the public. You can
use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
While these guidances contain no collections of information, they
do refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information
in FDA's guidance entitled ``Establishing That a Tobacco Product Was
Commercially Marketed in the United States as of February 15, 2007''
have been approved under OMB control number 0910-0775.
III. Electronic Access
Persons with access to the internet may obtain an electronic
version of the guidances at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, https://www.fda.gov/TobaccoProducts/
[[Page 71875]]
Labeling/RulesRegulationsGuidance/default.htm, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Dated: October 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-22976 Filed 10-17-23; 8:45 am]
BILLING CODE 4164-01-P
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